Personalized live-remote exercise training for cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a personalized, live-remote exercise program designed specifically for cancer survivors experiencing fatigue, reduced physical fitness, anxiety, and depressive symptoms. Participants will receive guidance from certified exercise specialists via video conferencing while exercising at home. The goal is to improve health-related quality of life and address the main complaints of the participants. The study aims to determine if this remote approach can overcome barriers to traditional supervised exercise.

Why it matters

Who can join: the full rules

Inclusion Criteria:

To be eligible to participate in this study, a subject must be:

* 18 years of age or older
* Diagnosed with any type of invasive cancer and have received systemic chemotherapy as part of their primary cancer treatment
* Within the timeframe of 12 weeks to 1 year after the completion of their primary cancer treatment with curative intent. Primary treatment, in this context, includes surgery, radiotherapy, and/or chemotherapy. For patients undergoing endocrine, targeted, or immunotherapy, their treatment must not be scheduled to be discontinued within the next 6 months.
* No evidence of distant metastatic disease (i.e., no diagnosis of metastatic disease in the regular clinical trajectory)
* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
* Presence of at least one of the following side-effects: fatigue (measured using EORTC QLQ-C30 fatigue symptom scale, score \>39), perceived low physical functioning in daily life (measured using EORTC QLQ-C30 physical functioning scale, score \<83), anxiety or depressive symptoms (measured using PHQ-ADS \> 20), and/or CIPN (measured using 2 PRO-CTCAE items, score \>0) for patients who received neurotoxic chemotherapy. Cut-off values are based on established thresholds.19-21
* Access to good quality and stable internet connection to access the live-remote training sessions.
* Able and willing to perform the exercise program and wear the activity tracker at least one week after T0 and before T2, T4, and T5 measurements and during training and online assessment sessions.
* Able to read, speak and understand the main country language.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Too physically active (i.e., \>210 minutes/week of self-reported moderate-to-vigorous or leisure and sports activities; this threshold has also been used in other exercise RCTs, such as PREFERABLE-EFFECT22, and fits activity levels of all participating countries) or participation in an exercise program comparable to the LION exercise program.
* Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication
* Participated in the intervention group of an exercise study during cancer treatment
* Inability to complete the testing or training sessions or any other contraindications for exercise as determined by the treating physician, including:
* Severe neurologic or cardiac impairment according to ACSM criteria
* Uncontrolled severe respiratory insufficiency or dependence on oxygen suppletion in rest or during exercise
* Uncontrolled pain All these exclusion criteria are formulated to ensure safe participation in the LION exercise program
* Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the treating physician
* More than 1 week not able to attend training sessions during the LION intervention period

Where it's running

• University Medical Center Utrecht
  Utrecht, Netherlands Recruiting

Study contacts

• Study coordinator: Evelyn Monninkhof, PhD
• Email: e.monninkhof@umcutrecht.nl
• Phone: +3161118187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.